The Effectiveness of Aspirin on Preventing Pre-eclampsia

Phase 4

• Conditions: Pre-Eclampsia
• Interventions: Drug: Aspirin

• Registration Number: NCT04656665
• Lead Sponsor: The Third Affiliated Hospital of Guangzhou Medical University

Brief Summary

This study will explore the effectiveness of low-dose aspirin on preventing pre-eclampsia in high-risks pregnant women by comparing the incidence of pre-eclampsia and pregnancy outcomes.

Detailed Description

Currently，low-dose aspirin is a commonly used drug to prevent pre-eclampsia. Many guidelines recommend starting low-dose aspirin in early pregnancy in high-risks pregnant women. However, the applicable population and use method of aspirin are still controversial in clinical practice. This study will explore the effectiveness and use method of low-dose aspirin by comparing the incidence of pre-eclampsia and pregnancy outcomes.

Study Timeline

• Study First Submitted: 2020-11-11
• Study First Submitted QC: 2020-11-30
• Study First Posted: 2020-12-07
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-09
• Last Update Posted: 2021-03-10
• Study Start: 2021-03-15
• Primary Completion: 2022-12-14
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 600

Inclusion Criteria

• Age between 18-55 years

• Gestational age between 12-20 weeks of pregnancy

• High risk of developing pre-eclampsia

  • At least one of the following risk factors: Pre-eclampsia in a previous pregnancy , Multiple pregnancy，Diabetes Mellitus(Type 1 or 2), Chronic Hypertension，Renal disease, Autoimmune disease.
  • At least two of the following risk factors: Primiparity，Pre-pregnancy Body Mass Index ≥28kg/m2, Age ≥35 years, Family members have a history of pre-eclampsia.

• Maternal informed conset obtained

Exclusion Criteria

• Contraindication to aspirin therapy (including but not limited to allergy and high bleeding risk)
• Patient with known intention to terminate pregnancy
• Fetal abnormalities detected （including but not limited to major fetal malformation and FGR）
• Severe heart, liver, renal disease who can not burden the experiment
• Alcohol and drug abuse
• Being in another drug experiment within 3 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
75mg	Aspirin	Take 75mg of aspirin daily in tihis group
100mg	Aspirin	Take 100mg of aspirin daily in this group

Primary Outcome Measures

Name	Time	Method
Incidence of pre-eclampsia	1 year	Record the number of pre-eclampsia in each group and compare whether there are statistical differences in the incidence of each group

Secondary Outcome Measures

Name	Time	Method
Postpartum hemorrhage	1 year	Record the number of postpartum hemorrhage in each group and compare whether there are statistical differences in the incidence of each group
Preterm birth	1 year	Record the number of preterm in each group and compare whether there are statistical differences in the incidence of each group
Placental abruption 4/5000 Placental abruption	1 year	Record the number of placental abruption in each group and compare whether there are statistical differences in the incidence of each group
Fetal growth restriction	1 year	Record the number of FGR in each group and compare whether there are statistical differences in the incidence of each group